Paclitaxel, foreign exchange among drags on BD's Q4

Still, executives are optimistic about integration of the 2017 acquisition of Bard, set to deliver $100 million in projected fiscal 2020 savings.

By David Lim • Nov. 5, 2019

Hips and knees help Zimmer beat Wall Street amid growing Stryker rivalry

The orthopaedics giant's third-quarter sales growth topped 2% for just the third time in the past three years, with analysts at Stifel concluding the "multi-year turnaround is well on track, if not ahead of schedule."

By Maria Rachal • Updated Nov. 5, 2019

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

As Essure implant return deadline nears, FDA study enrollment inches up

The birth control device, which Bayer stopped selling in December 2018, has been linked to nearly 33,000 reports of adverse events, including 49 deaths.

By Susan Kelly • Nov. 5, 2019

Abbott circulatory support system Class I recall linked to 1 death

A calibration system error resulting from electromagnetic interference may cause the pump to slow or stop and the console screen to blank.

By Dana Elfin • Nov. 4, 2019

5 breakthrough devices qualify under finalized faster outpatient payment path

CMS said Medicare spending on the five approved devices, which do not need to meet substantial clinical improvement requirements to qualify for the pass-through payments, will be about $116 million in 2020.

By Susan Kelly • Nov. 4, 2019

Stryker goes to extrem(iti)es in $4B Wright Medical takeout

Worth $5.4 billion including debt, the deal dwarfs the K2M buyout and sent shares in extremities device maker Wright Medical soaring almost 30%.

By Maria Rachal • Updated Nov. 4, 2019

Device aimed at curbing 'dead-in-bed' opioid effects wins FDA breakthrough status

The physician-owned startup Med-botics licensed the patented method from Oregon Health Science University, and changed the technology to be worn on the wrist. The system originally needed to be wheeled on a cart.

By Dana Elfin • Nov. 1, 2019

New tech add-on payment for innovative dialysis products final in ESRD, DME rule

Following criticism from industry, CMS did not go through with a plan to use technology assessments to determine comparableness to older items to help establish fee schedule amounts for durable medical equipment.

By David Lim • Nov. 1, 2019

Medtronic thoracic stent graft system approved in Japan

The device addresses common attributes and conditions in the Japanese patient population such as greater aortic fragility, smaller anatomy and aortic wall stress, the director of the Japanese Society for Vascular Surgery said.

By Nick Paul Taylor • Nov. 1, 2019

Teleflex raises outlook despite taking $8.7M hit tied to sterilization facility closure

CEO Liam Kelly told analysts its sterilization provider has yet to get a "clear line of sight as to when that facility may be reactivated."

By Nick Paul Taylor • Nov. 1, 2019

Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority

FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.

By David Lim • Oct. 31, 2019

Abiomed targets 'TAVR-like' adoption for protected PCI

Investors appear optimistic about the company's strategy, with its stock up more than 10% in morning trading despite the specter​ of FDA's questions about survival outcomes with Abiomed's right heart pump in February.

By Maria Rachal • Oct. 31, 2019

Smith & Nephew ups outlook a day before new CEO takes helm

Sales of sports medicine joint repair products rose 12.2%, the biggest jump yet in a year that's seen growth of at least 11% each quarter. 

By Nick Paul Taylor • Oct. 31, 2019

FDA puts J&J's Ethicon surgical stapler recall in top risk category

Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.

By Nick Paul Taylor • Oct. 31, 2019

Mako momentum lifts Stryker results amid core spine drag

Despite new competition from Zimmer Biomet's total knee application for Rosa, one Stryker exec called pricing for the Mako joint replacement robot "extremely stable" as the company expects 2019 organic sales growth near 8%.​

By Maria Rachal • Oct. 30, 2019

Medtronic developing fully implanted LVAD with FDA breakthrough support

Medtronic's HeartWare left ventricular assist device to treat advanced heart failure has lost ground to Abbott's HeartMate system, but its forthcoming tech could be an alternative that does not rely on an external power source.

By Susan Kelly • Oct. 30, 2019

It's official: EC confirms 2-year Eudamed delay

The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects. 

By Dana Elfin • Oct. 30, 2019

Surmodics gets breakthrough tag for critical limb ischemia device

The Minnesota medtech, which is also in the midst of testing a drug-coated balloon licensed by Abbott, now has a boost from FDA in bringing to market a sirolimus-delivering device designed to prevent amputation and death.

By Nick Paul Taylor • Oct. 30, 2019

FDA again warns of leak risk with Endologix AAA grafts

Regulators are concerned about new data pointing to a roughly 1 in 10 probability of mortality related to blood leaking into the aneurysm.

By Susan Kelly • Oct. 29, 2019

Sanford agrees to $20M settlement to resolve kickback allegations

The case centered on implants sold by a physician-owned distributorship and allegations a Sanford Health neurosurgeon used those devices to perform medically unnecessary procedures.

By Nick Paul Taylor • Oct. 29, 2019

A UK challenger to da Vinci seeks to chip away at robotic surgery 'monopoly'

Having filed a submission with FDA and won a CE mark, CMR Surgical has a head start on household names like Medtronic and J&J, all of which are seeking a slice of the robot-assisted minimally invasive surgery market.

By Maria Rachal • Oct. 28, 2019

Abiomed says right-heart pump protocol boosts survival in postmarket data

The medtech is aiming to reverse slowed demand by demonstrating that a higher patient mortality rate in postmarket results for its right-heart system, compared to premarket data, is due to sicker patients receiving the device.

By Susan Kelly • Oct. 28, 2019

Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body

BSI joins Dekra Germany as designated under the In Vitro Diagnostic Regulation ahead of its 2022 implementation date.

By Dana Elfin • Oct. 28, 2019

BD to suspend sterilization plant after FDA warning on device shortages

BD agreed Monday to temporarily halt operations at a Georgia ethylene oxide medical device sterilization facility, allowing regulators to assess surrounding air quality. The medtech doesn't anticipate disruptions to product availability.

By Maria Rachal • Updated Oct. 28, 2019

Deal wave expected as private equity eyes orthopaedic practices

The business of replacing hips and knees is a lucrative area for investors as joint replacements are set to rise and care migrates to outpatient settings.

By Samantha Liss • Oct. 25, 2019